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Completed

NCT Number: NCT07436585

CGM-Guided Acarbose for Painful Diabetic Neuropathy

This Phase II pragmatic hybrid effectiveness-implementation trial tests whether acarbose, titrated using continuous glucose monitoring (CGM) to blunt post-prandial excursions, reduces 4-week pain area-under-the-curve (AUC) versus placebo in adults with painful diabetic peripheral neuropathy (DPN) and high glycemic variability. Secondary objectives assess CGM variability metrics, microvascular reactivity, inflammatory markers, safety, and feasibility of a pharmacist-led titration workflow using loaner CGMs across multi-region community clinics.

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Key information

Conditions

Diabetes Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shifa International hospital

Lahore, Pakistan

About this study

Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE >50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Age 18-75 years.
  • Type 2 diabetes ≥1 year; HbA1c 7.0-10.0% within 8 weeks of randomization.
  • Painful DPN meeting clinical criteria; average daily pain NRS ≥4 during run-in.
  • High CGM variability on 7-10 day run-in (e.g., MAGE >50 mg/dL).
  • Stable analgesic regimen ≥4 weeks pre-baseline.
  • Able to use CGM and ePRO; provides informed consent.

Exclusion:

  • Type 1 diabetes; non-diabetic neuropathies.
  • Contraindications to acarbose (e.g., chronic intestinal malabsorption, inflammatory bowel disease).
  • eGFR <45 mL/min/1.73 m²; significant hepatic disease (ALT/AST >3× ULN).
  • Use of α-glucosidase inhibitors within 3 months.
  • Recent change (<3 months) in GLP-1/GIP agonists, SGLT2i, or basal/bolus insulin strategy.
  • Pregnancy/lactation; other conditions compromising safety/assessments.

Treatment and study plan

Acarbose 50 mg

Drug

Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated)

Placebo

Drug

Matching placebo; identical titration schedule

Primary outcomes

  1. Daily pain AUC

    Time frame: baseline→Week 4

    Daily pain AUC (ePRO; 0-10 NRS). Method: trapezoidal AUC of daily NRS scores; higher AUC = worse pain. Daily pain area under the curve derived from the Numeric Rating Scale for Pain (NRS). The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. AUC is calculated using the trapezoidal method from daily NRS scores over the assessment period. Higher AUC values indicate greater overall pain burden.

  2. CGM MAGE (mg/dL)

    Time frame: baseline→Week 4

    CGM MAGE (mg/dL)

Secondary outcomes

  1. CGM Time-in-Range (70-180 mg/dL, %)

    Time frame: baseline→Week 4

    CGM Time-in-Range (70-180 mg/dL, %)

  2. Skin microvascular reactivity

    Time frame: baseline→Week 4

    Skin microvascular reactivity by laser speckle contrast imaging

  3. Serum IL-6

    Time frame: baseline→Week 4

    Serum IL-6 (pg/mL)

  4. Patient Global Impression of Change (PGIC)

    Time frame: Week 4

    Patient Global Impression of Change (PGIC). Patient Global Impression of Change (PGIC) assessed on a 7 point Likert scale ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate improvement; higher scores indicate worsening.

Sponsors and collaborators

Lead sponsor

Shifa International Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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